Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Engineer II

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

Career development with an international company where you can grow the career you dream of.Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.An excellent retirement savings plan with a high employer contributionTuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

Leading an active lifestyle is important to the many people we serve. In Abbott’s Heart Failure division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in electrophysiology and heart failure, allowing people to restore their health and get on with their lives. 

The Opportunity

Our Design Assurance Engineer II assures new or modified products conform to requirements and establish compliance with the quality system.  They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

What You’ll Work On

Execute and support on-time completion of Design Control DeliverablesSupport on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projectsAccountable for Design Verification and Validation planning & execution, statistical analysis, including active cross-functional root-cause analysis investigation & resolution activitiesLead or support Risk Management activities from product Concept through CommercializationSupport design test and inspection method development, and lead method validation activitiesEnsure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gapsSupport manufacturing process development & qualification for new product commercialization and product changesSupport internal & external audit responsesSupport product re-certificationsSupport the establishment of objective, measurable, discrete, and verifiable customer and product requirementsSupport objective component specification definitions, supplied component sampling plan development, and vendor qualificationsSupport execution of biocompatibility and sterilization qualificationsComplete Document Change Request Reviews in a timely and objective mannerAdditional duties may be identified by functional management based on the current project/business objectives.Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.Performs other related duties and responsibilities, on occasion, as assigned.

Required Qualifications 

Bachelor level degree in Engineering or Technical Field2-5 years’ experiencePrevious Quality engineering experience and demonstrated use of Quality tools/methodologiesSolid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organizationAbility to work in a highly matrixed and geographically diverse business environment.Ability to work within a team and as an individual contributor in a fast-paced, changing environment.Ability to leverage and/or engage others to accomplish projects.Multitasks, prioritizes and meets deadlines in timely manner.Strong organizational and follow-up skills, as well as attention to detail.Ability to travel approximately 10%, including internationally.Ability to maintain regular and predictable attendance.

Preferred Qualifications

Prior medical device experience preferredExperience working in a broader enterprise/cross-division business unit modelASQ Certified Quality Engineer / Six Sigma Green Belt CertificationWorking understanding of FDA, GMP, and ISO 13485Working understanding of the following standards 60601, 62304, &/or 14971

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on X @AbbottNews.

The base pay for this position is $60,000.00 – $120,000.00. In specific locations, the pay range may vary from the range posted.